Study on Nab-Sirolimus and Endocrine Therapy for Recurrent Low Grade Serous Ovarian Cancer (NARETO)

Sponsor: University of Oklahoma

Sponsor score: 40

ClinicalTrials ID:NCT06494150

Provider View

This clinical trial is testing the effectiveness and safety of a new treatment combining nab-sirolimus and endocrine therapy (Fulvestrant) for patients with recurrent low grade serous ovarian cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well a combination of nab-sirolimus and Fulvestrant works in treating patients with low grade serous ovarian cancer that has come back. The study will also monitor the safety of this treatment approach.

Description

Patients diagnosed with low grade serous ovarian cancer that has returned will receive a combination treatment of nab-sirolimus and Fulvestrant. Nab-sirolimus will be given on days 1 and 8, and Fulvestrant on days 1 and 15 of the first cycle, then every 21 days as long as the cancer is not growing or spreading and there are no severe side effects. Patients will undergo regular tests and exams during the treatment and will be monitored for up to 2 years after completing the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed low-grade serous ovarian cancer that has returned.
  • Must have measurable cancer as defined by specific medical criteria.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have adequate bone marrow, liver, and kidney function.
  • At least 4 weeks must have passed since any major surgery.
  • At least 2 weeks must have passed since any radiation therapy.
  • Must have signed an informed consent form.
  • Must be at least 18 years old.
  • Can have other cancers if they do not interfere with this study.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after the study.

Exclusion Criteria

  • Cannot have previously received nab-sirolimus or similar drugs.
  • Cannot have allergies to nab-sirolimus or similar drugs.
  • Cannot be on high doses of steroids or other immunosuppressive drugs.
  • Cannot have active infections requiring IV antibiotics recently.
  • Cannot have severe lung problems.
  • Cannot have serious heart conditions or recent strokes.
  • Cannot be allergic to albumin.
  • Cannot be pregnant or breastfeeding.
  • Cannot have untreated brain metastases.
  • Cannot have certain viral infections like active hepatitis B or C.
  • Cannot have uncontrolled high blood pressure.
  • Cannot be taking certain medications that interfere with the study drugs.

Locations

FACILITYZIPCITYSTATE
OU Health Stephenson Cancer Center73117Oklahoma CityOklahoma

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